The LEADLESS Pacemaker IDE Study (Leadless II)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02030418|
Recruitment Status : Unknown
Verified April 2018 by Abbott Medical Devices.
Recruitment status was: Active, not recruiting
First Posted : January 8, 2014
Last Update Posted : April 13, 2018
Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker.
Following completion of enrollments in the IDE, patients will continue to be enrolled in the continued access phase of the study under the same protocol.
|Condition or disease||Intervention/treatment||Phase|
|Bradycardia||Device: Leadless Pacemaker||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1567 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||March 2020|
Experimental: Leadless Pacemaker
Device: Leadless Pacemaker
Patients will undergo an attempted leadless pacemaker implant
- Complication-Free Rate [ Time Frame: 6 months ]
- Pacing thresholds and R-wave amplitudes within the therapeutic range [ Time Frame: 6 months ]
- appropriate and proportional rate response during graded exercise testing [ Time Frame: 3-6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030418
|Principal Investigator:||Vivik Reddy, MD||MOUNT SINAI HOSPITAL|